This study is assessing the safety, tolerability and immune response rate the of mDC3 vaccine in patients with colorectal cancer.
Participants in this study will undergo apheresis, a medical procedure whereby blood is passed through a machine to separate its different components. They will receive the drug cyclophosphamide a few days before receiving the vaccine itself and will also receive a booster vaccine 8 weeks later. Blood will be taken weekly and participants will be monitored in order to assess the effects of the vaccine. The estimated total enrollment for the study is 12 participants. It began on March 12th 2019 and is predicted to be completed by October 2021.
- Stage I and II hypermutated colorectal cancer (CRC)
- Surgically resected disease
- Male or female patients 18+ years of age
- ECOG performance status 0-1
- Certain laboratory values, performed within 14 days prior to consent
- Subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial.
- Provide written informed consent
- Prior malignancy within 3 years that may put subject at risk
- Pregnant or nursing women
- Concurrent treatment with systemic immunosuppressants including corticosteroids, calcineurin inhibitors, antiproliferative agents within 2 weeks of consent. Local (inhaled or topical) steroids or replacement dose prednisone are permitted.
- Known allergy to eggs
- Any uncontrolled intercurrent illness or active ongoing infection that may put subject at additional risk
This study is taking place at the University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104. For more information, please contact Emerging Medicine on 855.216.0098 or at PennCancerTrials@emergingmed.com.
This study is Sponsored by the University of Pennsylvania, with Kim Reiss-Binder, MD. as the Principal Investigator.
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